Description
Regulatory Affairs Consultant (CTD, BLA, NDA) - Remote - French or Dutch speaking
One of our Blue Chip Clients is urgently looking for a Regulatory Affairs Consultant.
For this role you can work remotely, but you will need to spend 1 day per week onsite in Flanders, Belgium.
Please find some details below:
Min 3 years' experience
Scope of work:
o Support regulatory submissions (CTD, BLA, NDA,) of the products by informing site colleagues of regulatory requirements and by authoring the dossier.
o Liaise with regulatory colleagues to communicate and resolve potential issues.
o Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance.
o Manage timely responses to Board of Health requests resulting from life cycle submissions in markets or products under responsibility.
o Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier.
o Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals.
Experience:
Master degree in Life sciences (eg industrial pharmacist, biomedical sciences, bio-engineer,..)
Minimum 3 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring CTD, BLA) and quality.
Scientific knowledge, analytical skills associated with technical writing skills to issue RFT regulatory documentation
Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)
Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
Dynamic, flexible, enthusiastic and eager to learn
Ability to work under minimal supervision and in a team
Fluent in written and spoken English
CMC experience is a real asset
Please send CV for full details and immediate interviews. We are a preferred supplier to the client.